Girardi | Keese

There's an app for that: FDA sets new regulations on medical apps

With the smartphone generation upon us, it seems like there’s an app for everything. From easy ordering at your local pizza place to turning on your alarm system even though you’re miles away, mobile-software companies seem to have found a solution for just about all of society’s woes.

But along with that innovation comes liability, especially when it comes to new software apps that act just like medical devices. The concern for many people here in California, including workers at the Food and Drug Administration, is that without regulation, these apps could be putting thousands of people in harm if they fail or give incorrect readings.

In an attempt to remedy this before it becomes a widespread problem, the FDA published a new guidance document that carefully lays out what products it intends on scrutinizing for safety reasons and which ones it intends on leaving alone. The new document is already being commended by many in the legal community as a huge leap forward from a similar draft that was submitted two years ago.

Among those apps that will be closely monitored will be those that act similar to a medical device, more specifically those that require sensors to gather data. Apps that measure the heart’s electrical signals or analyze eye movements to diagnose balance disorders are among those that the FDA has specifically cited as falling under new regulations. Other applications that can activate medical devices remotely, such as insulin delivery systems, will also be closely monitored because of the high risk to patients if the app fails or delivers the incorrect command to the medical device.

While the hope is that these new regulations will mitigate the number of cases of liability down the road, readers of our blog know that they will not eliminate them all together. Patients may still suffer injury from a defective or dangerous mobile-software product. The hope is that these new regulations will afford victims the protection they need if a personal injury suit needs to be filed.

Source: The Wall Street Journal, "FDA Updates Guidance on Mobile-Software Apps," Thomas M. Burton, Sept. 23, 2013

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